None listed
Conditions
Brief summary
This study aims to investigate the feasibility of implementing a whole-of-lifestyle intervention, the Younger Women’s Wellness after Cancer Program (YWWACP), to promote health-related quality of life. Who is it for? You may be eligible for this study if you are a woman aged 18-50 years inclusive, have completed any intensive treatment (surgery, chemotherapy, radiotherapy) for breast cancer in the previous 24 months and have no metastatic disease. Study details Participants will be randomly allocated to either a control arm who will receive standard care, or an intervention arm who will receive materials for a 12-week program designed to help them self-manage their chronic disease risk. They will also have three 30-60 minute individual, video consultations at weeks 1, 6 and 12 with a registered nurse. Participants will be asked to complete a variety of questionnaires throughout the program. Data from this study will go towards assisting the design of future programs to decrease the likelihood of treatment-related chronic disease for women with breast cancer.
Interventions
The intervention is a 12 week structured health promotion intervention targeted at improving health related quality of life and reducing chronic disease risk factors in women between 18 and 50 years of age who have previously been treated for cancer. All women in the intervention arm will receive health education material, including a specially-designed Program Journal, and access to the study-specific program website. The Book includes sections on healthy eating, sleep, exercise advice, tips fo
The intervention is a 12 week structured health promotion intervention targeted at improving health related quality of life and reducing chronic disease risk factors in women between 18 and 50 years of age who have previously been treated for cancer. All women in the intervention arm will receive health education material, including a specially-designed Program Journal, and access to the study-specific program website. The Book includes sections on healthy eating, sleep, exercise advice, tips for managing fatigue and stress, mindfulness, and will encourage women to bring together these various components of the health education provided and incorporate them into their lives over a 12-week period. The Book includes a weekly exercise planner, where women are encouraged to use this journal daily and to plan ahead for their exercise in the following week. It is expected participants will engage with the materials for ~1-2 hours per week. Participants will receive access to self-directed resources (via the website) and three 30-60 minute individual, personalised consultations (via video conference) at weeks 1, 6 and 12 will be provided by a registered nurse trained in the intervention. The nurse consultations will include individual goal setting as well as discussion and health education about physical activity, healthy eating, stress, sleep, menopause and sexuality after cancer and strategies to promote intervention adherence. Adherence to the intervention will be assessed during these consultations.
Sponsors
Choices Wesley Support Centre, The Wesley Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Women who have completed any intensive treatment (surgery, chemotherapy, radiotherapy) for breast cancer in the previous 24 months (can be on endocrine or targeted therapy). 2. Aged between 18 years and 50 years (inclusive). 3. Reside in Australia. 4. Have no metastatic disease/advanced disease. 5. Have access to the internet. 6. Own, or have access to, a computer, tablet device or smartphone. 7. Willing and able to comply with all study requirements, including intervention, timing and nature of required assessments. 8. Able to speak and read in English to ensure consent is informed and documentation of participant-reported outcome measures can be adhered to. 9. Voluntary written informed consent.
Exclusion criteria
1. Any clinical contraindication that precludes safe completion of the program in the judgement of the project team.
Outcome results
None listed